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Lumbar Spine SurgeryNCT05698914

Telehealth Mindfulness After Spine Surgery

A study testing Telehealth mindfulness-based intervention (MBI) and Telehealth Education in people with Lumbar Spine Surgery and Chronic Low-back Pain, run by Vanderbilt University Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this pilot clinical trial is to compare two behavioral interventions for patients who are recovering from lumbar spinal surgery for a degenerative spine condition. The study aims to answer the following questions: 1. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Telehealth mindfulness-based intervention (MBI) and Telehealth Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
1 siteUnited States
Study dates
22 Feb 2023to 11 Jul 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • English-speaking adults
  • Aged 18 years and older
  • Scheduled for a laminectomy and/or fusion at Vanderbilt Spine Center
  • Scheduled for their first lumbar spine surgery
  • Radiographic evidence of a degenerative condition including but not limited to spinal stenosis, spondylosis with or without myelopathy, and spondylolisthesis
  • Presence of back and/or lower extremity pain persisting for at least 3 months
  • Access to stable internet.
  • Able to participate in weekly, remote sessions with a study therapist for 8 weeks after surgery

Who cannot join

  • Microsurgical technique as the primary procedure (i.e. isolated laminotomy or microdiscectomy)
  • Having surgery for the primary indication of a spinal deformity
  • Having surgery secondary to pseudarthrosis, trauma, infection, or tumor
  • Current/history of a primary psychotic or major thought disorder or hospitalization for reasons related to psychosis (e.g. Schizophrenia, brief psychotic disorder, delusional disorder). Medication-induced psychosis is not exclusionary.
  • Diagnosis of Alzheimer's disease or another form of dementia
  • Traumatic Brain Injury (greater than mild severity)
Show all 10Show fewer
  • History of bipolar disorder or dissociative disorder
  • Active substance use disorder (in past month)
  • Current Posttraumatic Stress Disorder (PTSD) symptoms (in past month)
  • Active suicidal ideation with intent

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

Other trials in United States

About this study

Official title: Postoperative Telehealth Mindfulness Intervention After Lumbar Spine Surgery: Pilot Randomized Controlled Trial

The goal of this pilot clinical trial is to compare two behavioral interventions for patients who are recovering from lumbar spinal surgery for a degenerative spine condition. The study aims to answer the following questions:

  1. Is it feasible and acceptable to deliver the interventions and conduct the study procedures in this patient population?
  2. Do the interventions benefit patients with regard to pain-related, functional, opioid use, and psychosocial outcomes at 3 and 6 months after surgery, and does one intervention have more benefit than the other?
Read more

Participants will be asked to do the following:

  1. Complete self-report questionnaires online before spine surgery, and around 2 weeks, 3 months, and 6 months after spine surgery.
  2. Complete a sensory pain task before spine surgery, and around 2 weeks, 3 months, and 6 months after spine surgery.
  3. Around two weeks after surgery, participants will be randomly assigned by chance to one of two behavioral interventions - Mindfulness or Education. Participants will then be asked to attend 8, weekly sessions with a study treatment coach over telehealth (online with camera and microphone).
Read the detailed description

This is a pilot randomized clinical trial comparing a telehealth mindfulness-based intervention (MBI) with a telehealth education intervention (EDU) for patients recovering from spine surgery. The procedures will be as follows:

  1. Enroll patients prior to lumbar spine surgery for a degenerative spine condition at the Vanderbilt Comprehensive Spine Center. Recruitment, enrollment, and screening will occur at a routine preoperative clinic visit or over the phone.
  2. Two weeks after enrolled participants complete surgery, they will be randomized in a 3:2 ratio to either MBI or EDU condition, respectively. Randomization will be stratified by chronic preoperative opioid use (yes/no). The randomization assignments will remain concealed from all study personnel until the time of randomization. The outcome assessor and surgical providers will remain blinded to participant study condition.
  3. Within four weeks of surgery, participants will begin the assigned intervention. The interventions will consist of meeting with an interventionist for eight, weekly one-on-one telehealth MBI sessions over an online telehealth platform. MBI sessions will led by a clinical psychologist and will be 75 minutes long (90 minutes for the first session). EDU sessions will be led by a physical therapist and will be 30 minutes long. Sessions will be audio recorded and monitored for fidelity.
  4. Participants will complete self-report assessments online prior to surgery, two weeks after surgery (pre-intervention), three months after surgery (post-intervention) and 6 months after surgery.
  5. Participants will complete quantitative sensory testing assessments of pain tolerance, pain threshold, and temporal summation of pain prior to surgery, two weeks after surgery, three months after surgery, and 6 months after surgery.
Being tested
Telehealth mindfulness-based intervention (MBI), Telehealth Education
Keywords
Mindfulness, Telehealth
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telehealth mindfulness-based intervention (MBI)Behavioural

    The telehealth MBI is adapted from Mindfulness-based cognitive therapy for chronic pain and consists of eight, weekly 75-minute individual sessions (90 minutes allotted for the first session) with a mindfulness interventionist delivering the intervention over telehealth (online with audio and video camera) in addition to the patient receiving their usual postsurgical care. Participants will begin the intervention after completing the 2-week postoperative assessment and within 4 weeks after surgery. Participants will be asked to practice skills between sessions approximately 20-40 minutes per day.

  • Telehealth EducationBehavioural

    Participants will receive a written educational booklet at the time of randomization (within 2-4 weeks after surgery) and 8, weekly telehealth sessions lasting 30 minutes in addition to usual postsurgical care. The educational materials are reviewed individually with the participant during weekly telehealth sessions (online with audio and video camera) by a physical therapist.

Study groups in NCT05698914
Study groupRoleWhat they receive
Telehealth mindfulness-based intervention (MBI)ExperimentalEight, weekly telehealth mindfulness sessions delivered one-on-one with mindfulness instructor
Receives: Behavioral: Telehealth mindfulness-based intervention (MBI)
Telehealth Education (EDU)Active comparatorEight, weekly post-surgical educational sessions delivered one-on-one with physical therapist
Receives: Behavioral: Telehealth Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Enrollment Rate

    Proportion of participants approached who are eligible and enroll in the study

    Measured: Preoperatively, from when the potential participant is approached for recruitment until the time at which a potential participant is either eligible and consents to enroll in the study, or is ineligible or declines to enroll in the study, up to 2 weeks.

  2. Participant Study Retention

    Proportion of participants who complete the study (6 month assessment)

    Measured: 6 months postoperative

  3. Session Attendance

    Average proportion of sessions attended out of 8 sessions

    Measured: Through 3 months postoperative

  4. Intervention Satisfaction

    Proportion of participants reporting overall satisfaction levels greater than or equal to 7 out of 10

    Measured: 3 months postoperative

  5. Home Practice Completion

    Average days practiced out of days assigned practice (MBI group only)

    Measured: Through 3 months postoperative

Secondary outcomes (18)
  1. Pain Interference Short-form 8a

    Pain Interference short-form 8a from the Patient Reported Outcomes Measurement Information System scale. Measures interference of pain over the past 7 days. Consists of 8 items with response options from 1 = not at all to 5 = very much. The total score is a T-score based on a population with mean score of 50 and standard deviation of 10. A lower score indicates lower pain interference, or a better outcome.

    Measured: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative

  2. Pain Bothersomeness

    One item assessing how bothersome pain has been in the past 7 days from 0 = not at all to 4 = extremely. A lower scores indicates lower pain bothersomeness.

    Measured: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative

  3. Back Pain Intensity

    1 item assessing back pain intensity on a scale of 0-10 over the past 7 days, described as pain when off medication or medication has worn off. Lower scores indicate less pain, or better outcome.

    Measured: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative

  4. Leg Pain Intensity

    1 item assessing leg pain intensity on a scale of 0-10 over the past 7 days, described as pain when off medication or medication has worn off. Lower scores indicate less pain, or better outcome.

    Measured: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative

  5. Anxiety Short Form 4a

    Anxiety short-form 4a - Patient Reported Outcomes Measurement Information System. 4 items assessing anxiety symptoms in the past 7 days (e.g. "I felt fearful") with response options from 1 = never to 5 = always. The total score is a T-score based on a population with mean score of 50 and standard deviation of 10. Lower scores represent lower anxiety, a better outcome

    Measured: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative

  6. Physical Function

    Physical Function short-form 4a - Patient Reported Outcomes Measurement Information System. 4 items assessing physical function in the past 7 days (e.g. "Are you able to do chores such as vacuuming or yard work?") with response options from 1 = Unable to do to 5 = Without any difficulty. The total score is a T-score based on a population with mean score of 50 and standard deviation of 10. Higher scores represent better physical function, a better outcome

    Measured: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative

  7. Depression Short Form 4a

    Depression short-form 4a - Patient Reported Outcomes Measurement Information System scale. 4 items assessing depressive symptoms over the past 7 days (e.g. "I felt worthless) with response options from 1 = never to 5 = always. The total score is a T-score based on a population with mean score of 50 and standard deviation of 10. A lower score indicates less depression, a better outcome.

    Measured: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative

  8. Sleep Disturbance Short Form 4a

    Sleep disturbance short-form 4a - Patient Reported Outcomes Measurement Information System scale. 4 items assessing sleep disturbance over the past 7 days (e.g. "I had difficulty falling asleep) with response options from 1 = not at all to 5 = very much (1 item reverse-scored). The total score is a T-score based on a population with mean score of 50 and standard deviation of 10. A lower score indicates less sleep disturbance, a better outcome.

    Measured: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative

  9. Oswestry Disability Index

    Assesses impact of pain on level of functioning in 10 areas (e.g. walking, sleep, social life) with 10 items with response options with scores 0 to 5. Total scores are calculated as a percentage, ranging from 0% to 100%. Lower scores indicate a lower level of disability due to pain, a better outcome.

    Measured: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative

  10. Pain Catastrophizing Scale

    13 items assessing thoughts and feelings when in pain (e.g. "I become afraid that the pain will get worse" with response options ranging from 0 = never to 4 = all the time. Total scores range from 0 to 52 units on the scale. Lower scores indicate lower pain catastrophizing, a better outcome.

    Measured: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative

  11. Pain Self-efficacy Questionnaire

    10 items assessing confidence in ability to do certain things despite pain (e.g. "I can enjoy things, despite the pain" with response options 0 = not at all to 6 = completely. Total scores range from 0 to 60 units on the scale. Higher scores indicate greater pain self-efficacy, a better outcome.

    Measured: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative

  12. Perceived Stress Scale - 4

    4 items assessing perceived level of stress in the past month (e.g. "In the last month, how often have you felt that you were unable to control the important things in your life?"), with response options ranging from 0 = never to 4 = very often (2 items reverse-scored). Total scores range from 0 to 16 units on the scale. Lower scores indicate lower perceived stress, a better outcome.

    Measured: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative

  13. Tampa Scale for Kinesiophobia -13

    13 items assessing fear of movement (e.g. "I'm afraid that I might injure myself if I exercise" with response options ranging from 1 = strongly disagree to 4 = strongly agree. Total scores range from 13 to 52 units on the scale. Lower scores indicate lower levels of kinesiophobia, a better outcome.

    Measured: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative

  14. Five Facet Mindfulness Questionnaire - 15

    15 items assessing 5 facets of mindfulness, including observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Response options range from 1 = never to 5 = always (7 items reverse scored). Total scores are an average of the sum of all items, ranging from 1 to 5 units on the scale. Higher scores indicate higher levels of mindfulness, a better outcome.

    Measured: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative

  15. Number of Participants Indicating They Currently Use Opioids

    Participants were asked in one item "Are you currently taking an opioid medication?" Response options included "Yes" or "No." A response of Yes counted as 1 and No counted as 0 when calculating total frequency of participants reporting current opioid use.

    Measured: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative

  16. Pain Tolerance

    The duration of time participants tolerated an inflated blood pressure cuff: Using an ischemic task involving squeezing a dynamometer followed by inflated blood pressure cuff on arm, the time in seconds at which the participant indicated they could no longer tolerate the stimulus (inflated blood pressure cuff). Scores could range from 0 seconds to 300 seconds, as the task was discontinued at 300 seconds if reached prior to the participant indicating to stop the task.

    Measured: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative

  17. Pain Threshold

    Duration at which participants indicate a stimulus is experienced as painful: Using an ischemic task involving squeezing a dynamometer followed by inflated blood pressure cuff on arm, the point in seconds at which the stimulus (inflated blood pressure cuff) is first reported by the participant as painful. Scores could range from 0 seconds to 300 seconds, as the task was discontinued at 300 seconds if participants did not yet indicate that the stimulus was painful.

    Measured: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative

  18. Temporal Summation of Pain

    Using a punctate stimuli (von frey hairs of 100g and 180g of force to the finger), the difference between reported pain intensity during a single prick and the reported highest pain intensity during repeated brief pricks at a constant intensity. Pain intensity was measured on a scale of 0 to 100. The difference score was calculated by subtracting the pain intensity with single prick from the pain intensity with repeated pricks and could range from 0 to 100 units of difference on the pain intensity scale. Lower values are a more favorable outcome.

    Measured: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2023
  2. Study start22 Feb 2023
  3. Primary completion11 Jul 2025
  4. Study completion11 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05698914
Sponsor's protocol ID
221711
Other IDs
K23AT011569
Status last verified
May 2026
First submitted
27 Dec 2022
Last updated
13 Aug 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Telehealth mindfulness-based intervention (MBI) and Telehealth Education in people with Lumbar Spine Surgery and Chronic Low-back Pain, run by Vanderbilt University Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Enrollment Rate (time frame: Preoperatively, from when the potential participant is approached for recruitment until the time at which a potential participant is either eligible and consents to enroll in the study, or is ineligible or declines to enroll in the study, up to 2 weeks.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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